The NGO delegation to the Board of UNITAID offers its strong support for the proposal of WTO least developed country Members to extend the transition period for enforcing protections for pharmaceutical related patents and clinical data “for as long as the WTO member remains a least developed country.” The proposal, IP/C/W/605, was offered by Bangladesh on behalf of LDCs at the 24-25 February 2015 meeting of the WTO TRIPS Council and will be taken forward at its next 1 June 2015 meeting.
In addition to seeking an unconditional extension of the current pharmaceutical transition period set to expire on 1 January 2016, the LDCs also seek a waiver from the General Council with respect to two additional transition measures, namely mailbox and exclusive marketing rights provisions under Articles 70(8) and 70(9) of the TRIPS Agreement.
LDC Members are unequivocally entitled to the requested extension and waiver under paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health, under the text of the original 2002-2016 pharmaceutical transition decision, and under Article 66.1 of the TRIPS Agreement which states that LDC Members “shall” be granted extension upon properly motivated request.
Although LDC Members already have some degree of assurance with respect to not having to grant patent rights on pharmaceutical products or to protect pharmaceutical data under the 2013 TRIPS Council Decision extending the general TRIPS transition period until 1 July 2016, the proposed pharmaceutical extension is clearer, stronger, and longer and thus will help guarantee continuing access to affordable medicines in the poorest and most capacity-constrained countries in the world.
The benefit of the proposed extension is that it will guarantee freedom from pharmaceutical patents and data protections (and mailbox and exclusive marketing rights) for as long as a country remains so technologically and developmentally constrained that it is an LDC. There will also be no ambiguity whatsoever in the likely text of the eventual decision – it will allow LDCs not only to deny patents on pharmaceutical products but to not enforce any existing pharmaceutical patents as well. This level of assurance has been used by dozens of LDCs over the past 13 years, especially with respect to antiretroviral medicines. LDCs’ rejection of pharmaceutical patents under the extension in turn allows donors and countries to lawfully procure generic ARVs at the lowest possible price and gives assurance to generic producers that they will not be sued by Big Pharma companies.
The granting of this requested extension should be non-controversial. Its passage will further UNITAID’s ability to support market entry of affordable new medicines, diagnostics, and prevention technologies to address the HIV/AIDS, tuberculosis, malaria, and hepatitis C pandemics in LDCs. In an era of constrained resources but dramatically unmet need, it is crucial that LDCs have the policy space to be free of monopoly protections on medicines so that they can fulfill their human rights duty to ensure access to medicines for all.